CANCER CARE OUTCOMES RESEARCH AND SURVEILLANCE CONSORTIUM
Release Date: August 24, 2000
RFA: CA-01-013 - (Reissued as RFA-CA-09-503)
National Cancer Institute
Letter of Intent Receipt Date: October 15, 2000
Application Receipt Date: January 24, 2001
PURPOSE
The Division of Cancer Control and Population Sciences (DCCPS), National
Cancer Institute (NCI), invites applications from domestic institutions for
cooperative agreements to support a new collaborative research consortium that
would conduct Cancer Care Outcomes Research and Surveillance (CanCORS).
Research institutions are invited to apply for primary data collection and
research site (PDCR) awards that would support the conduct of prospective
studies in newly diagnosed cohorts of lung and colorectal cancer patients.
These prospective studies will collect information about medical care
practices used to manage patients over the course of their disease, various
outcomes associated with these practices, and information about patient and
provider behaviors and perceptions. This information will be collected in
order to address three goals reflecting major NCI research priorities:
1) Enhance monitoring and understanding of the processes of cancer care and
the patient-centered factors influencing prognosis in population-based cohorts
of patients.
2) Establish a system for examining the relationship between the processes of
care and clinical and patient-centered outcomes, with emphasis on measuring
the dissemination of state-of-the-science interventions and their association
with better quality outcomes in the general population of cancer patients.
3) Examine disparities in the receipt of state-of-the-science cancer care and
factors that contribute to disparities in outcomes, such as health-related
quality of life (QOL), and identify ways to lessen those disparities.
This RFA is the first major step by NCI to support the development of a system
for obtaining details about cancer care beyond the initial diagnosis and
limited treatment data that are now routinely collected in high quality
population-based cancer registries. This research will help build the
information base needed for measuring and improving the quality of cancer care
in the US.
This RFA cooperative agreement will fund individual grantees who will be
formed into the CanCORS Consortium whose purpose will be to collaboratively
collect and analyze process-outcome relationships in patients newly diagnosed
with lung or colorectal cancer. Applicants must propose specific research
hypotheses to serve as the scientific foundation of this data collection
system. In addition, separate applications are invited to support a CanCORS
Statistical Coordinating Center (SCC). The primary objectives of the SCC will
be to develop and support the collection of standardized, core data across
individual research sites, and to serve as the central repository for the
analysis of pooled data.
NCI has established a CanCORS website which includes answers to frequently
asked questions to further assist potential applicants:
http://www-dccps.ims.nci.nih.gov/ARP/cancors.html.
RESEARCH OBJECTIVES
Background
The overall goal of the national cancer research program is to reduce
mortality and morbidity from cancer in the US population. Current
surveillance systems, including the Surveillance, Epidemiology, and End
Results (SEER) Program established in 1973, track incidence, survival, and
mortality rates in parts of the population. Specific measures of the burden
of cancer in terms of process and outcomes of care were identified in the
“Measures of Progress Against Cancer” report to the U.S. Senate Appropriations
Committee in 1990 (see ref #1). In that report, an expert panel recommended
that the NCI systematically track patterns of care and assess services
delivered to cancer patients. The NCI responded to this recommendation by
conducting SEER-based, cross-sectional studies of practice patterns,
establishing the SEER-Medicare data base, and sponsoring other special
targeted surveys. External review groups and committees, most recently the
Institute of Medicine’s (IOM) National Cancer Policy Board (NCPB) (see ref
#2), the Cancer Surveillance Research Implementation Group
(http://dccps.nci.nih.gov/DCCPS/SIG/), and NCI’s Progress Review Groups,
including the Colorectal Cancer Progress Review Group
(http://osp.nci.nih.gov/Prg_assess/PRG/CPRG/default.htm have all urged the
NCI and other research agencies to expand cancer care surveillance research
beyond these efforts, and to include the study of the process and outcomes of
cancer care in national, longitudinal, population-based patient cohorts. One
example of such studies is the Prostate Cancer Outcomes Study (PCOS)
(http://www-dccps.ims.nci.nih.gov/ARP/PCOS/index.html).
One of the NCPB’s specific recommendations was to “support national studies of
newly diagnosed cancer patients using data sufficiently detailed to assess
patterns of care and their relationship to valued outcomes” (Recommendation
8). A second was to investigate why specific segments of the population are
not receiving quality cancer care, and to explore ways of removing access
barriers (Recommendation 10). The earlier Cancer Surveillance Research
Implementation Plan (prepared by the Surveillance Implementation Group, NCI,
March 1999) also noted this suggestion, under priority area #1, suggesting
the “collection of data on patterns of care, health status, morbidity, and
quality of life as well as cohort studies of newly diagnosed registered cancer
patients for the purpose of documenting levels and trends in these
parameters”. This RFA is part of the NCI’s response to these recommendations,
as embodied in the NCI Director’s remarks to the IOM on 5 October 1999. It is
also consistent with the NCI Director’s two challenge areas regarding quality
of care and health disparities, and is consistent with the mission of the
DCCPS to monitor and report on diverse measures of the burden of cancer in the
population.
This expansion of research on cancer care delivery is complementary to the
goals of the Department of Health and Human Services Quality Improvement
Initiative and also to the trans-departmental Quality Interagency Coordination
Task Force (QuIC). The vehicle for coordinating these efforts in cancer care
is the NCI-chaired Quality of Cancer Care Committee, a transagency working
group that includes representatives from other Federal agencies involved in
the delivery, payment, or regulation of cancer care.
The long-term goal of the research to be supported by this RFA is to provide a
stronger, more representative empirical evidence base of process-outcome
linkages in the delivery of care used to treat, monitor, and palliate cancer
patients. The goal is not to promulgate guidelines or recommendations by a
specific organization or institution, or to compare the patterns of care in
the community setting against an external "standard" suggested by a specific
guideline. However, the extent to which different guidelines are used and the
effect of their use on patient outcomes is an example of an association that
can be examined in response to this RFA.
A central focus of NCI’s outcomes research program is on developing methods
for defining, measuring, and reporting on the quality of cancer care.
Currently, the NCI and other Federal and private research organizations
support cross-sectional studies describing cancer practice patterns that rely
primarily on cancer registries that are based on hospital records or linked
data bases such as SEER-Medicare. The CanCORS initiative represents the next
important and logical step in furthering the research agenda on quality of
cancer care by identifying process and outcome measures that can eventually be
incorporated into a national data system for monitoring and improving that
care. Studies supported by this RFA will permit much more in-depth
assessments of cancer care and its relationship to outcomes in diverse
populations and delivery settings than any prior systematic research efforts
in this field. Such large scale studies have yet to be supported because of
their size and complexity. Over time, the knowledge gained from CanCORS will
help to identify the core elements of a national, shared data system on
quality of care that can be used by patients, providers, researchers, and
health plans.
Definitions
AWARDEE: The institution to which the UO1 grant is awarded, including both
PDCR sites and the SCC.
NCI PROGRAM DIRECTOR: Scientist administrator from the NCI extramural staff,
the Program Director will not only provide normal stewardship for the UO1
grants awarded under this RFA, but will also be involved in the scientific
coordination and collaboration within the CanCORS Consortium and will
coordinate and facilitate interaction among the awardees.
PRINCIPAL INVESTIGATOR (PI): The investigator who is designated by the
applicant organization to direct the project to be supported by the UO1 grant.
The PI will assume the responsibility and accountability to the applicant
organization officials and to the NCI for performance and proper conduct of
the research supported by the UO1 mechanism. Each institution may have more
than one CanCORS PI, and a single person may be the PI for applications that
include both lung and colorectal cancer.
NCI SCIENTIFIC STAFF: Scientific staff from NCI’s extramural and intramural
programs called upon to provide their expertise to the CanCORS Consortium
efforts.
CanCORS CONSORTIUM: The newly formed entity created under this RFA by
joining together individual awardees for the purpose of conducting
collaborative research on process-outcome relationships in a longitudinal
cohort of lung and colorectal cancer patients.
PRIMARY DATA COLLECTION AND RESEARCH (PDCR) SITE: An awardee, consisting of
an institution or organization which is responsible for primary data
collection of core processes and outcomes of cancer care, reporting core data
to the central SCC, and performing statistical analysis of pooled data. PDCR
sites may have their own data collection infrastructure or may partner with
other data collection entities.
STATISTICAL COORDINATING CENTER (SCC): Single awardee responsible for data
transfer from PDCR sites, storage, documentation, and formatting for pooled
statistical analysis by investigators from PDCR sites or from the SCC. Will
also support development of standardized data collection at participating PDCR
sites and advancement of study design and statistical techniques for the
Consortium as a whole.
CORE DATA ELEMENTS: Variables pertaining to processes of care (or
interventions to manage, treat, and palliate cancer patients) and outcomes of
care (including traditional endpoints such as recurrence and mortality, as
well as patient-oriented outcomes such as quality of life, satisfaction, and
economic burden) to be collected by all participating PDCR sites for pooled
analysis.
SPECIAL RESEARCH PROJECTS: Smaller ancillary studies proposed by individual
applicants that complement the collection and/or the analysis and
interpretation of core data. Each PDCS applicant must propose at least one
but no more than two such projects, and SCC applicants must propose at least
one but no more than three special projects.
CanCORS STEERING COMMITTEE (CSC): A committee consisting of the PI’s from
each of the PDCR sites, the PI of the SCC, the NCI Program Director, and one
person from the NCI scientific staff as designated by the NCI Program
Director. A PDCR site may include an additional representative on the CSC if
that site is participating in data collection for both lung and colorectal
cancer. The Chair of the CSC will be one of the PI’s as selected by the CSC.
The CSC can admit additional non-federal non-voting members as they deem
necessary. The CSC will provide overall scientific direction for the CanCORS
Consortium and establish and oversee policies and procedures.
DATA STANDARDS COMMITTEE (DSC): Formed by the CSC, the DSC will be
responsible for defining the core data elements selected by the CSC or its
designees. The DSC will be responsible for assisting and coordinating the
collection and reporting of standardized, quality data by all participating
sites to the SCC. The DSC will be chaired by the PI of the SCC, and will
include other members named by the CSC. Non-federal persons from outside the
Consortium may be added to advise the DSC, if such expertise is not available
from within the Consortium.
PARTICIPATION MONITORING COMMITTEE (PMC): Formed by the CSC, the PMC will be
responsible for monitoring the adherence of all research sites to the uniform
study protocol established for collection of core data elements, and
monitoring patient response rates, attrition, and cooperation of local
providers with data collection activities. The PMC members from within the
Consortium will be named by the CSC. Non-federal persons from outside the
Consortium may be added to advise the PMC, if such expertise is not available
from within the Consortium.
CanCORS WORKING GROUP (CWG): Named by the CSC, this group will consist of
persons from outside the CanCORS Consortium who will provide advice (of its
individual members) to the CSC regarding overall strategies, study designs,
analysis plans, and results.
Scope
The study of lung and colorectal cancer practice patterns and associated
outcomes can be achieved by means of a coordinated, prospective study
conducted by 5-12 PDCR sites with a central SCC for data coordination and
reporting. The PDCR sites will enroll and collect core data on a total of
approximately 6,000 newly diagnosed cases per cancer. Enrolling a large
sample of patients for longitudinal studies will permit assessments of
process-outcome relationships across diverse population sub-groups and health
care delivery systems. Applicants may participate in the study of one or both
cancers. Each PDCR site will be required to collect standardized, core
variables pertaining to cancer-specific practices used to treat, monitor, and
palliate cancer patients, and patient outcomes associated with these
practices. Other core data elements will be likely confounding factors, such
as comorbidity, socio-demographic, and economic variables. All core data will
be reported to the central SCC for pooled analysis to be carried out
collaboratively by all participating investigators. Final selection of core
variables to be collected across participating research sites will be jointly
determined by the CanCORS Steering Committee (CSC) during the first year of
the project. In addition to information about cancer care and outcomes,
applicants are invited to propose collection of other factors potentially
associated with long-term prognosis, such as lifestyle factors. Such
information may be proposed as part of the core study, or as a special
research project to be conducted in selected sub-samples of enrolled patients.
Given the disproportionately high cancer burden borne by some population
subgroups, emphasis should be placed on assessing reasons for disparities in
processes and outcomes of cancer across age, gender, socioeconomic and racial-
ethnic groups. Research questions on this topic should focus not only on
describing differences in care, but on investigating the underlying reasons
for such variations related to patient characteristics such as age and
comorbidity, patient preferences, provider characteristics, and health system
organization and reimbursement attributes.
The development of large, observational studies in community settings serves
as an important adjunct to the NCI’s clinical research program. The types of
studies to be carried out will complement what is learned from randomized
clinical trials by assessing the dissemination and impact of new knowledge in
the population. There exists a wide spectrum of evidence about the efficacy of
cancer treatments, ranging from treatments known to be efficacious based on
evidence from Phase III randomized clinical trials (RCT), to interventions for
which there is no clear consensus about the efficacy of various treatment
options. For such interventions, there are numerous other factors that may
dictate patterns of practice. For the sake of more clearly describing the
objectives of this RFA, these two categories are discussed separately below.
A. Treatments with proven efficacy from RCTs
The main focus of studies for such treatments will be to assess the
dissemination of evidence-based care to the larger, general population. The
assessment should include cross-sectional descriptions of variations in
practice patterns in diverse care settings, and comparisons of cancer outcomes
in RCTs with outcomes observed in non-protocol settings. Dissemination of
RCT-proven interventions to the general population may be limited because
providers may not quickly adopt new treatments on the one hand, or patients in
community practices may not be directly comparable to participants in well-
controlled RCTs. Thus, it is important to measure outcomes of RCT-proven
therapies in population-based clinical settings. An improved understanding of
the many factors that encourage or inhibit patient access to efficacious
interventions is a necessary first step in the overall research agenda aimed
at increasing the proportion of cancer patients in the US who receive high
quality cancer care. Applicants will also be asked to address provider
issues. For example, physician attitudes and knowledge, and health care
delivery system factors might affect the dissemination of cancer treatments.
Access to specialists versus generalists may also influence processes and
outcomes that could be assessed across different types of health care delivery
organizations. Applicants should consider the assessment of multiple factors
that may be associated with poor dissemination of RCT-proven cancer-related
practices among vulnerable populations defined by age, socioeconomic status,
and some racial/ethnic groups who traditionally experience higher mortality
from cancer.
B. Treatments with unproven mortality benefits or therapeutic options not yet
compared in RCTs
As in the case of “proven” therapies for cancer based on RCTs, it is first
necessary to characterize practice patterns where there is no clear consensus
about “best” practices and the underlying reasons for variations across
populations, including patient factors, preferences, and provider factors.
The main purpose of measuring outcomes will differ in the case of unproven
interventions, since there is no standard of care based on RCT evidence
against which to compare community-based outcomes. Information to be obtained
through linking process with outcomes in observational studies can serve at
least two important purposes. First, the association between processes and
outcomes of cancer care in situations of uncertain efficacy will enhance
clinical decision making by giving both patients and clinicians an expanded
evidence base upon which to choose among competing therapeutic strategies.
Observational studies cannot definitively establish the superiority of one
treatment versus another in terms of curative potential. However, information
about other outcomes important to patients, such as side-effects and QOL, can
be obtained in diverse patients and delivery settings to provide a more
complete picture of possible outcomes from specific treatments. Additionally,
observational studies in large, representative cohorts can help develop
hypotheses to be tested in new clinical trials by raising questions about the
cost-benefit tradeoffs of therapies that are currently delivered in everyday,
“real-world” health care settings.
Another research objective is to measure the prevalence of long-term
functional limitations due to cancer or sequelae of treatments, as well as the
effectiveness of palliative treatments for these sequelae or disease-specific
functional limitations. Applicants should describe the potential significance
of information as the foundation for new research directions focusing on the
development of cost-effective behavioral and health services interventions
designed to alleviate cancer morbidity in the population. However,
intervention research per se will not be supported under this RFA.
Research Objectives
PDCR site applicants must specify research hypotheses relating to lung or
colorectal cancer practices and associated outcomes. Specific hypotheses to be
proposed by applicants should address the following five general research
objectives of this RFA:
1. Cross-sectional analysis of practice patterns for cancer patients according
to multiple patient clinical and sociodemographic characteristics; assessment
of other determinants of access to cancer care services according to patient,
health care delivery system, and physician characteristics; evaluation of
awareness of cancer clinical trials and CancerNet.
2. Analysis of underlying reasons for variations in cancer practices and
outcomes among vulnerable populations, defined by age, socioeconomic status
and racial-ethnic identification.
3. Longitudinal assessments of outcomes, and how outcomes are mediated by
variations in the processes and structure of care over the course of the
disease, i.e., during initial, continuing, or terminal phases of cancer care.
4. Identification of patient, provider, and health system factors influencing
the dissemination and effectiveness of interventions that have been
demonstrated in randomized studies to reduce cancer-specific mortality or
morbidity, or improve health-related QOL.
5. Assessments of the contribution of modifiable lifestyle factors on
prognosis and health outcomes. Such information may be collected on specific
sub-samples for whom such information is most relevant.
PDCR site applicants are encouraged to incorporate methodological studies to
identify, develop, and validate process and outcome measures most useful for
clinical decision making, as well as to develop more efficient, standardized,
automated data collection methods on processes and outcomes of cancer care.
Applicants are encouraged to consider novel ways of prospectively collecting
information on processes of care, for example, through the use of emerging
clinical informatics systems.
PDCR site applicants are invited to suggest sampling designs that permit
oversampling of specific sub-groups defined by sociodemographic or clinical
criteria to address high priority areas of interest. In order to track
temporal trends in care, or to track newly emerging technologies that arise
during the award period, applicants may propose the identification of new,
additional incident cohorts of lung or colorectal cancer patients to be added
during the term of the award and supported through administrative supplements.
Core Data Elements
For the purpose of assessing cancer care delivery in the general community
setting, awardees must reach agreement on the core measures and variables to
be collected across all primary data collection sites. PDCR site applicants
must propose candidate core data elements based on specified research
hypotheses. This serves as the beginning of the process of selecting final
core measures. The final selection of core variables will be made during the
first year of the project by the CSC (see more on the structure and function
of the CSC under Terms and Conditions). Specific instruments or
questionnaires to measure core elements will be selected by the CSC, or
through other procedures established by the CSC. For example, a designated
sub-committee may be charged with responsibility for instrument selection or
development of original instruments as required.
The NCI’s CanCORS webpage (http://www-dccps.ims.nci.nih.gov/ARP/cancors.html)
includes an outline of general core process and outcome measures that serves
as a reference point for prospective applicants to encourage some commonality
among the individual applicants. However, applicants are not restricted to
these core issues or questions. The website also contains a separate link
describing examples of disease-specific questions relating to processes of
care for lung and colorectal cancer that span the continuum of care spanning
from diagnosis through terminal care. These suggested measures serve as the
foundation for core data elements to be collected by all Consortium research
sites. After awards are made applicants must be willing to work with other
Consortium sites to select and define these core measures. Applicants should
review these outlines in preparation of their applications.
Study Protocol
A crucial element of the collection of core data in the CanCORS Consortium
will be the study protocol specifying the precise methods and timing for
collecting core data uniformly. Although applicants are required to propose a
protocol for data collection specific to to their own site in applications,
the common protocol to be used by all research sites will be finalized by the
CSC or its designees during the initial year of the project. For the purpose
of helping applicants estimate the resources necessary to collect core data,
it is anticipated that there will be 2 waves of a mixed mode (self-
administered mail initially) patient survey, performed at baseline
(approximately 4-6 months post-diagnosis) and repeated approximately 1-2 years
later. Provisions and procedures for interviewing surrogates or next-of-kin
for deceased patients should be described in applications. A modest payment
for the study participants, such as $20-50, may be included to enhance
participation and compensate participants for their time. Research
applications will also require a baseline medical record review, involving
abstraction of all sources of cancer-related providers of care within the
first 1-2 years of diagnosis, and a re-abstraction of a sample of cases (such
as 20-40%) 1-2 years after the baseline medical record reviews. Additional
contacts to enhance accrual and retention, such as informational or
promotional materials, with patients or providers, should also be described in
applications.
Composition of PDCR Sites
This RFA invites applications from research organizations, including those
within academic institutions, cancer centers, state agencies, professional or
managed care organizations. Participants in the Consortium may also include
member institutions of Cooperative Groups or Community Clinical Oncology
Program (CCOPs), large health care delivery organizations or professional
societies, providing such organizations can demonstrate inclusion of a
heterogeneous population of cancer patients with respect to socio-demographic
characteristics and diverse health care systems with respect to organization
and reimbursement characteristics. Organizations that lack access to such
population-based patient or health care system samples may propose the
development of innovative data collection systems for ensuring the necessary
surveillance coverage of populations and health care practices appropriate to
the research supported by this RFA. Coverage may also be accomplished through
partnerships with data collection entities, such as population-based cancer
registries, or other organizations with the capability of developing
innovative health care data collection systems.
Ideally, the composition of each PDCR site will be interdisciplinary, with
expertise in clinical sciences, psychosocial and behavioral research,
epidemiology, health services research, and biostatistics, at a minimum.
Establishing local collaborations with relevant patient and provider partners,
such as representatives from major professional societies, may be helpful in
facilitating access to primary data sources essential for measuring community
practice patterns and outcomes. Participation of patient advocacy groups is
also strongly encouraged.
Applications for PDCR sites will be strengthened by the participation of
individuals with clinical expertise in the organ system under study, and
individuals with statistical expertise in the analysis of observational data
on health care services and outcomes.
PDCR site applications must include documentation of prior experience in the
collection of data regarding studies of cancer practice patterns and long term
cancer outcomes. Such experience may include identification of incident
patient populations within defined areas, abstraction of baseline clinical
data from medical records, active follow up for vital status, patient surveys,
and close ties with local providers. Experience with previous epidemiologic
or health services research studies that involve similar activities to those
required by this RFA should be documented as part of the demonstration of
capability
Approximate Timetable
During year 1, each participating research site and the SCC will work
collaboratively to select core data elements, finalize the study protocol for
collection of core elements, obtain IRB approvals, and develop and test data
collection and reporting procedures. Contacts with local provider groups and
patient advocates will be made to facilitate cooperation of cancer patients
with the research effort. Enrollment and initial data collection efforts will
occur in years 2-3, including initial patient surveys and obtaining patient
consent for review of medical records. Medical record abstraction to obtain
records-based core variables will occur during years 3-4. Depending on the
research hypotheses to be addressed as part of the core studies, additional
surveys and secondary reviews of medical records may occur in years 4-5.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State and Local governments, and eligible agencies of
the Federal Government. Applications from minority individuals, women, and
persons with disabilities, are encouraged to apply as principal investigators.
Foreign applicants are not eligible to apply.
SPECIAL REQUIREMENTS
Terms and Conditions of Award
The following terms and conditions will be incorporated into the award
statement and provided to the Principal Investigator(s) as well as the
institutional offical at the time of award. The reporting requirements, the
plans for NCI’s involvement in the Cancer Care Outcomes Research and
Surveillance (CanCORS) Consortium and the requirements for coordination among
investigators from the individual sites are described.
Under the cooperative agreement, a partnership will exist between the
recipient of the award and the NCI, with assistance from the NCI in carrying
out the planned activity. The following terms and conditions pertaining to
the scope and nature of the interaction between the NCI and the investigators
will be incorporated in the Notice of Grant Award. These terms are in
addition to, and not in lieu of, otherwise applicable OMB administrative
guidelines; HHS Grant Administration Regulations at 45 CFR Parts 74 and 92,
and other HHS, PHS, and NIH Grant Administration policy statements.
The inability of an awardee to meet the performance requirements set forth in
the Terms and Conditions of Award, or significant changes in the level of
performance, may result in an adjustment of funding, withholding of support,
suspension or termination of award.
1. Awardee Rights and Responsibilities
A. All awardees
All awardees must join the CanCORS Consortium and cooperate fully in the
planning and implementation of collaborative projects designed to address
research objectives set forth in the RFA. Within this framework, the awardees
will have primary and lead responsibility for the project as a whole,
including research design and protocol development. Data from the
collaborative projects will be pooled for joint analysis, interpretation and
publication by Consortium investigators in accord with policies and procedures
established by the CanCORS Steering Committee (CSC). Awardees are obligated to
adhere to joint decisions for publications and research direction decided on
by the CSC.
All awardees are required to attend semi-annual meetings to discuss and review
scientific and technical aspects of implementation, and analysis and
presentation of data results. At least two investigators (including the PI),
but no more than four investigators, from each awardee must attend these
meetings. The first meeting will be convened by the NCI Program Director and
held shortly after initiation of the award. At the initial meeting, Principal
Investigators from each of the award recipients will specify the structure and
function of a cooperative organizational unit, referred to as the CSC.
In order to address the wide range of substantive and methodological issues
that may arise during the course of implementation of collaborative protocols,
awardees will agree to attend up to two additional small working group
meetings per year to facilitate progress on specific analyses, if deemed
necessary by the CSC.
Awardees are required to provide quarterly reports on progress of special
research projects to the CSC, who may then distribute information to other
CanCORS investigators as appropriate.
B. Primary Data Collection and Research (PDCR) sites
PDCR site awardee responsibilities are to:
1. Enroll a minimum number of patients (1,000 per cancer) in order to achieve
the overall sample size objectives of the Consortium (6,000 per cancer).
Enrollment is defined as obtaining consent for performing inpatient and
outpatient medical record reviews from patients or their next-of-kin over the
2-year accrual period.
2. Agree to participate in the Participation Monitoring Committee (PMC) to
assist in the specification of performance targets in terms of initial
response rates and attrition. These targets will be used by the CSC and PMC
as part of their role of ensuring that PDCR sites achieve and maintain high
rates of respondent participation.
3. Obtain access to three sources of information vital to core data
collection: pathology facilities, cancer patients or their next-of-kin, and
institutions and providers who possess records about the patient and the care
they received.
4. Adopt a common data collection protocol and use standardized data
collection instruments approved by the CSC to ensure uniform procedures across
individual site awardees.
5. Accept and implement the common processes and procedures approved by the
CSC or its designees for transmitting core data to the Statistical
Coordinating Center (SCC). Awardees must submit core data in timely manner to
the SCC to ensure such data is available for pooled analyses within the time
frame established by the CSC.
6. Assume lead responsibility for the study design, planning, completion of
statistical analysis and interpretation of pooled data.
7. Demonstrate a willingness to interact effectively with the SCC, discuss
their capability to participate in a consortium of research groups, and state
their willingness to help develop and follow the common protocol that will be
used to collect core variables.
8. Conduct at least one, and not more than two, special research project(s)
that complement core data collection or analysis, but that are separate from
the participation in the collection of core data elements.
C. Statistical Coordinating Center (SCC)
The SCC awardee must also participate actively in all meetings of the CanCORS
Consortium and provide scientific, statistical, and technical input into
discussions of pooled and collaborative research projects.
Specifically, the SCC awardee responsibilities are to:
1. Maintain data comparability processes to be developed by the CanCORS
investigators, and improve these processes where needed.
2. Serve as the central repository for pooled data by maintaining confidential
and secure mechanisms for transmitting electronic files for core data elements
to the SCC.
3. Provide centralized training to patient survey staff and medical record
abstraction personnel from the PDCR sites.
4. Examine and report on the quality of submitted data for the purpose of
pooled data analysis.
5. Provide data files in ready-to-analyze format (for example, in formats
recognized by common statistical packages such as SAS) to the PDCR site
investigator(s) responsible for the specific pooled study.
6. Provide the research expertise and collaboration to PDCR site
investigators on complex statistical issues for analysis of pooled data.
7. Assume leadership and coordination of regular conference calls of the CSC,
and maintaining good communications among all awardees during the term of the
project.
8. Conduct at least one, and not more than three, special research project(s)
that complement core data collection or analysis.
2. NCI Staff Responsibilities
The NCI Program Director will be responsible for normal stewardship of this
award, and will also have substantial scientific/programmatic involvement
during the conduct of this activity, through technical assistance, advice, and
coordination above and beyond normal program stewardship for grants. The NCI
Program Director will monitor and review the activities of the awardees for
relevance to the objectives of the RFA and other programmatic considerations.
The NCI Program Director will serve as a member of the CSC, and will designate
an additional NCI scientific staff person to serve on the CSC.
The NCI Program Director will convene the first of the semi-annual meetings
for award recipients to join the CanCORS Consortium. Throughout the term of
the project, the NCI Program Director will continue to facilitate and
coordinate interactions among the CanCORS awardees to ensure the standardized
collection of all core data elements selected by the CSC.
The NCI will have access to all data generated under this award consistent
with current HHS, PHS, and NIH policies. Periodically, the NCI Program
Director or designee will review data management and analysis procedures.
The NCI Program Director, or designated NCI scientific staff, will provide
information to the awardees about a wide range of data sources and methods
used in other studies to complement the design of collaborative projects. The
NCI Program Director will call upon other NCI scientific staff as needed to
provide advice on specific scientific and technical issues.
In addition to normally prescribed duties of program and grants staff, an
on-site program review at each awardee site will occur as early as 12 months,
but no later than 24 months, after award. The program review will be
conducted to evaluate progress of the site in the recruitment of research
subjects and collection of core data elements. At least four months prior to
these on-site program reviews, specific performance criteria will be provided
to sites by the NCI Program Director. These performance criteria will
include: minimum target levels of enrollment, survey response rates, access
to medical records for reviews, implementation of quality control for
collection, storage, and transmittal to the SCC, and study drop-out rates. The
minimum accrual targets will be initially developed and proposed by the PMC
(without NCI staff involvement in development of review criteria) and approved
by the NCI Program Director.
3. Collaborative Responsibilities
The CanCORS Steering Committee (CSC) is a committee consisting of the PI’s
from each of the PDCR sites, the PI of the SCC, the NCI Program Director, and
one person from the NCI scientific staff as designated by the NCI Program
Director. The NCI will have one vote. A PDCR site may include an additional
representative on the CSC if that site is participating in data collection for
both lung and colorectal cancer. The Chair of the CSC will be one of the PI’s
as selected by the CSC. The CSC can admit additional non-federal non-voting
members as they deem necessary. The CSC will:
1. Be the ultimate decision making body for the CanCORS Consortium, unless a
disagreement is brought to arbitration.
2. Establish administrative procedures (i.e., meeting dates, guidelines for
reporting, etc.) and methods by which all scientific/analytic requirements of
the RFA will be met.
3. Establish or approve collaborative study protocols, core data elements,
and instruments to collect core data within a timeframe to be established at
the first CanCORS meeting.
4. Approve protocols for special research projects occurring only at one PDCR
site or collaborative projects at multiple PDCR sites. The CSC may designate
this function to the PMC in order to ensure minimal respondent burden
regarding collection of core data elements.
5. Develop policies and procedures regarding publication or presentation of
data.
6. Meet separately during the course of the semi-annual CanCORS meetings. It
will also meet by conference call at least twice between the semi-annual
meetings.
7. Define and establish separate cancer-site specific working groups (for
lung and colorectal cancers) if deemed necessary, who would report to the CSC.
8. Establish a CanCORS Working Group (CWG) consisting of persons from
outside the Consortium who will provide advice (of its individual members) to
the CSC regarding overall strategies, study designs, analysis plans, and
results. The CWG will convene at least once each year. The CSC will be
responsible for naming members of the CWG and more specifically defining its
role.
9. Establish a Data Standards Committee (DSC), which will be responsible for
defining the core data elements selected by the CSC or its designees. The DSC
will be responsible for assisting and coordinating the collection and
reporting of standardized, quality data by all participating sites to the SCC.
The DSC will be chaired by the PI of the SCC, and will include other members
named by the CSC. Non-federal persons from outside the Consortium may be
added to advise the DSC, if such expertise is not available from within the
Consortium.
10. Establish a Participation Monitoring Committee, which will be responsible
for monitoring the adherence of all research sites to the uniform study
protocol established for collection of core data elements, and monitoring
patient response rates, attrition, and cooperation of local providers with
data collection activities. The PMC members from within the Consortium or
from among NCI staff will be named by the CSC. Non-federal persons from
outside the Consortium may be added to advise the PMC, if such expertise is
not available from within the Consortium. The PMC will identify the most
successful protocols for ensuring high participation and low attrition rates,
review data on participation and attrition rates as summarized by the SCC, and
recommend changes in protocols at PDCR sites if high participation or low
attrition rates are not maintained. The non-NCI members of the PMC will also
develop performance criteria measures (for example, regarding patient
enrollment and retention rates) for approval by the NCI Program Director to be
used in conducting on-site program reviews of the individual awardees. These
criteria will be developed within 8 months of the initial award.
The inability of an awardee to meet the performance requirements set forth in
these Terms and Conditions of Award in the RFA, or significant changes in the
level of performance, may result in an adjustment of funding, withholding of
support, suspension or termination of the award.
4. Arbitration Process
Any disagreement that may arise on scientific/programmatic matters (within the
scope of the award) between award recipients and the NCI may be brought to
arbitration. NCI will establish an arbitration process when a mutually
acceptable agreement cannot be obtained between the awardee and the NCI
Program Director. An arbitration panel (with appropriate expertise) composed
of one member selected by the awardees, one NCI nominee, and a third member
chosen by the other two members will be formed to review the NCI decision and
recommend a course of action to the Director, NCI. These special arbitration
procedures in no way affect the awardee's right to appeal an adverse action in
accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS
regulations 45 CFR Part 16.
MECHANISM OF SUPPORT
The administrative and funding instrument to be used for this program will be
a cooperative agreement (U01), an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH scientific and/or
programmatic involvement with the awardee is anticipated during performance of
the activity. Under the cooperative agreement, the NIH purpose is to support
and/or stimulate the recipient's activity by involvement in and otherwise
working jointly with the award recipient in a partner role, but it is not to
assume direction, prime responsibility, or a dominant role in the activity.
Consistent with this concept, the dominant role and prime responsibility for
the activity resides with the awardees for the project as a whole, although
specific tasks and activities in carrying out the studies will be shared among
the awardees and the NCI scientific staff.
The total project period for applications submitted in response to the present
RFA may not exceed 5 years. The anticipated award date is September 1, 2001.
Awards and level of support depend on receipt of a sufficient number of
applications of high scientific merit. Although this program is provided for
in the financial plans of the NCI, awards pursuant to this RFA are contingent
upon the availability of funds for this purpose.
This RFA is a one-time solicitation.
FUNDS AVAILABLE
The NCI intends to commit a total of approximately $6,000,000 in FY 2001 to
fund 5 to 12 new competing grants for PDCR sites plus one competing grant for
the SCC in response to this RFA, and $8-8.5M in each of years 2-5. The first
year amount is smaller than years 2-5 because data collection activities are
not anticipated to reach full implementation until year 2. Because the nature
and scope of the research proposed may vary, it is anticipated that the size
of each award will also vary.
It is anticipated that one award for the SCC will be made for approximately
$1,000,000 (including direct and Facilities and Administrative costs) per
year, and up to 6 awards to PDCR sites for each cancer site (lung and
colorectal) will be made for up to $600,000 (including direct and Facilities
and Administrative costs) per year, averaged over the 5-year term of the
award. Because a single PDCR site may request additional funds if
participating in data collection for both lung and colorectal cancer, the
total number of PDCR site awards may be fewer than 12. Special research
projects should not exceed 20% of the total budget.
Although the financial plans of the NCI provide support for this program,
awards pursuant to this RFA are contingent upon the availability of funds and
the receipt of a sufficient number of meritorious applications. At this
time, it is not known if competing renewal applications will be accepted
and/or if this RFA will be reissued.
INQUIRIES
Written and telephone inquiries concerning this RFA are encouraged. The
opportunity to clarify any issues or questions from potential applicants is
welcome. NCI has established a CanCORS website which includes answers to
frequently asked questions (FAQs) to further assist potential applicants:
http://www-dccps.ims.nci.nih.gov/ARP/cancors.html.
Direct inquiries regarding programmatic issues to:
Arnold L. Potosky, Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, Room 4005, MSC 7344
Bethesda, MD 20892-7344
Telephone: (301) 496-5662
FAX: (301) 435-3710
Email: potosky@nih.gov
Direct inquiries regarding review issues to:
Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8109, MSC-8329
Rockville, MD 20852 (express courier)
Bethesda MD 20892-8329
Telephone (301) 496-3428
Fax: (301) 402-0275
Email: tf12w@nih.gov
Direct inquiries regarding fiscal matters to:
Brian Albertini
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243, MSC 7150
Bethesda, MD 20892-7150
Rockville, MD 20852 (express courier)
Telephone: (301) 496-7239
Fax: (301) 496-8601
Email: albertib@gab.nci.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit, by October 15, 2000, a letter of
intent that includes a descriptive title of the proposed research, name,
address, and telephone number of the Principal Investigator, identities of
other key personnel and participating institutions, and number and title of
the RFA in response to which the application may be submitted.
Although a letter of intent is not required, is not binding, and does not
enter into the review of subsequent applications, the information allows NCI
staff to estimate the potential review workload, and to plan the review.
The letter of intent is to be sent to the program staff listed under INQUIRIES
by the letter of intent receipt date listed.
SCHEDULE
Letter of Intent Receipt: October 15, 2000
Application Receipt Date: January 24, 2001
Peer Review Date: May 2001
Review by NCAB Advisory Board: August 2001
Earliest Anticipated Start Date: September 2001
APPLICATION PROCEDURES
The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants. Applications kits are available at most
institutional offices of sponsored research and may be obtained from the
Division of Extramural Outreach and Information Resources, National Institutes
of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone
301/435-0714, E-mail: grantsinfo@nih.gov. For those applicants with internet
access, the 398 kit may be found at http://grants.nih.gov/grants/forms.htm.
Specific Instructions for PDCR Site Applications (Core)
In proposing objectives, hypotheses, measures, and statistical analysis plans
for the core component of the application, each PDCR applicant should assume
it is part of the collaborative group of CanCORS awardees and, therefore, is
making recommendations that would be considered for adoption by the group as a
whole. For example, in the proposed analysis plan pertaining to core
objectives, applicants should assume the availability of pooled core data to
be collected by all PDCR site awardees.
Applications to become a PDCR site within the CanCORS Consortium should
include the following components:
1. A statement of objectives, and specific research hypotheses regarding
process-outcome relationships for lung and/or colorectal cancer care.
Proposed hypotheses should have associated proposed core measures, including
important confounding factors such as comorbidity and sociodemographic
characteristics, to be collected by all PDCR sites. Background should
describe the scientific relevance and the importance of proposed core measures
for informing cancer care policies and/or clinical decision making. Examples
of general core measures, and suggested topics for disease-specific studies,
are available at the CanCORS website
http://www-dccps.ims.nci.nih.gov/ARP/cancors.html.
2. Description of population from which eligible cases will be ascertained,
and any characteristics of that population regarding access to cancer care
that may enhance or limit generalizability. Applicants should provide
evidence of socioeconomic diversity of sampled patients treated in diverse
health care delivery settings. The minimum number of patients for each cancer
(lung and colorectal) to be enrolled is 1,000 (enrollment defined here as
obtaining consent for performing inpatient and outpatient medical record
reviews from patients or NOK) over a maximum 2-year accrual period.
3. Plans and methods for recruitment and retention of research subjects
including the qualifications of the organization(s) for collecting data, and a
detailed plan for identifying, acquiring, and transmitting the core data to
the SCC. Applicants should also provide:
A. Evidence of ability to rapidly enroll newly diagnosed cases as part of
epidemiologic or health services studies. Applicants should propose
procedures to achieve at least 90% case ascertainment (of all eligible
cases) from pathology facilities serving their defined populations
within a six month time period following initial diagnosis;
B. Methods to conduct mixed mode patient surveys (mailed with phone or in-
person follow-up);
C. Methods to obtain appropriate consent from patients for medical record
reviews, and to obtain record reviews from all relevant providers
associated with delivery of cancer-related health care over the course
of the disease;
D. Methods for conducting comprehensive follow up to measure practice
patterns and outcomes in different phases of care including initial
treatment, surveillance for recurrence/progression and secondary
cancers, treatment for recurrence/progression, and end-of-life care.
Special attention should be given to the problems of attrition common to
all longitudinal studies, and methods for maintaining a high
participation rate among cases and community physicians and other health
care providers throughout the duration of the study;
E. Plans for obtaining cooperation of patients, next-of-kin, and providers
necessary for successful data collection efforts;
F. Proposed information technologies or information systems as part of
efficiently collecting standardized, core data elements on cancer care
practices and outcomes from diverse community medical settings.
Applicants may propose development and testing of innovative systems.
4. Description of quality control and assurance procedures for all phases of
the research proposed from data collection, storage, transfer and analysis.
In addition, it is essential that the level of data quality and quality
control of the data source for the sampling frame, such as a cancer registry
or other data system, be described. For example, recent descriptions of data
quality within cancer registries in North America have been developed by the
North American Association of Central Cancer Registries (NAACCR).
5. Plans for addressing the issue of patient confidentiality, including how
the records of all research subjects will be protected. The applicant must
include evidence and knowledge of legal issues pertaining to the collection
and analysis of data. When relevant, specific state and/or federal laws and
their impact on the project must be fully explained.
6. A preliminary analysis plan and statistical methods for addressing
proposed core research questions or objectives. Applicants are encouraged to
propose innovative statistical methods regarding development of new core
measures, assessment of patterns of care and associated outcomes in
observational settings, and/or survey design.
7. Demonstration of past experience and willingness to participate as a
collaborating research partner in Consortium activities, including the
collection of timely, consistent, standardized core data elements and
reporting of all de-identified information to a central SCC for the purpose of
supporting pooled analyses.
Applications should be flexible enough to accommodate further refinement and
integration with the other awardees for the same organ system. Potential
applicants at single research institutions may coordinate with each other to
meet minimum accrual targets and may submit common applications.
Applicants must include provisions for pilot core data collection during the
first year of the award. This will provide the opportunity to evaluate the
data collection protocol and methods for data collection and for ensuring high
response rates and gaining physician participation and access to patient
medical records. The pilot data collection effort may be conducted on small
samples of approximately 30-75 patients. Applicants are particularly
encouraged in this phase of the project to develop and test innovative
information technologies for standardized data collection from community
medical practices, as part of collecting either core data or data for special
research projects.
The page limit for the core research plan component is 25 pages for applicants
proposing one cancer, and 35 pages for applicants proposing to study both lung
and colorectal cancers. The research plan should address the specific
application criteria above using the following topic headings:
1. Research objectives and aims (separate for each cancer if applicable).
2. Background and significance (separate for each cancer if applicable).
3. Suggested core data elements. This section should suggest and justify
core measures to be collected to address research objectives, though specific
instruments are not required since those must be selected and agreed upon
during the first year of the project by consensus.
4. Proposed methods for enrolling and maintaining follow up of study
participants.
5. Data collection infrastructure including prior experience, and detailed
methods for obtaining, managing, transmitting the core data elements.
6. Preliminary analysis plan with statistical methods for analysis of core
research questions.
Special Research Projects (non-core studies)
Applicants must propose additional special research projects separate from the
core data collection component. These projects are smaller studies proposed
by individual applicants that complement the collection and/or the analysis
and interpretation of core data. Such special studies may include selected
samples of patients participating in the core study. Each PDCR site applicant
must submit at least one, and not more than two, research plan(s) for special
research project(s), separate from the participation in the collection of core
data elements to be described in the application. There is an additional five
page limit for each additional special research project. Separate budgets
should be presented for each non-core special research project.
For example, applicants may wish to assess the processes of treatment decision
making to better understand the interaction of patient, provider, and
institutional factors that may explain reasons for poor dissemination of
recommended therapies. This applicant might propose an ancillary study to be
conducted within a sub-sample of patients who are enrolled at the time of
initial diagnosis, and could thus report directly on factors, including the
provider and institutional influences, that affected their decision making.
Other examples of special studies may include, but are not limited to:
1. Research on innovative technical approaches for routinely collecting
information about cancer care and outcomes;
2. Studies of other factors beyond traditional medical care practices that may
be associated with long-term prognosis, such as use of complementary
medicines, or modifiable lifestyle factors such as diet, smoking, and physical
activity;
3. Utilization of emerging new technologies to treat or manage lung and
colorectal cancer patients;
4. The assessment of new prognostic biomarkers of long-term risk through
collection of blood or tissue specimens;
5. Proposal of innovative statistical methods for analyzing observational
data;
6. Surveys of physician knowledge, attitudes, and practices; studies of
health care delivery systems and their impact on cancer care practices.
The research plan for special studies is limited to 5 pages per project, and
should use the following topic headings:
1. Research objectives and aims
2. Background and significance
3. Research methods and design. Include specific details on how the sample
would be drawn from among participants in the core study.
4. Preliminary analysis plan with statistical methods proposed.
Specific Instructions for SCC Applications
A separate complete application is required from institutions applying to be
the SCC for the CanCORS Consortium. Applicants to the SCC component are NOT
required to be a PDCR site within the Consortium, though applicants for PDCR
sites may also submit an application to be the SCC.
The sources of data for this research effort are diverse and range from solo
practitioners in rural settings to multi-specialty groups within large,
structured managed care organizations in urban settings. The complexity of
integrating data from these multiple sources and the increasing use of
computerized medical record systems for clinical care necessitates the
development of novel data collection and editing systems. Therefore, one key
function of the SCC will be to develop automated systems to ensure high
quality, efficient reporting of core data from individual PDCR sites to the
SCC for eventual use in pooled analyses. Another key function of the SCC will
be to support and assist the PDCR sites in their development of standardized,
automated data collection methods tailored to their local health care
environments. Support for standardization across PDCR site local data
collection systems should help to ensure that core data elements are of
uniform, high quality across all participating sites. The SCC applicant must
describe the approach to soliciting cooperation from the all participating
PDCR sites and exercising appropriate leadership in matters of study design,
data acquisition, management, and analysis.
Applicants for the SCC should propose plans and methods with respect to data
management and coordination activities, including:
1. Plans for establishing and evaluating data collection and formatting
procedures to create comparable data files for pooled core data. The SCC
applicant should demonstrate an understanding of how to create comparable data
files from diverse sources and how to link the various subcategories of data
being collected for this research effort.
2. Procedures and methods for documenting core data elements and survey
questions that are likely to be included as core items in collaborative
studies. (see examples at http://www-dccps.ims.nci.nih.gov/ARP/cancors.html.)
3. Plans for working with primary data collection research sites to develop
quality control procedures for data collection, storage and transmission of
data to the SCC. While primary data collection research sites are responsible
for developing site-specific quality control procedures for data collection
and storage at their own sites, the SCC will be responsible for working with
all research sites to ensure that a standard of data quality is practiced at
all sites. The SCC will also be responsible for providing centralized
training of survey staff and medical record abstraction personnel from the
individual PDCR sites.
4. Detailed procedures for individual research sites to transfer all core
data to the SCC using file transfer protocols. The SCC applicant should
provide evidence of understanding and experience in creating a central data
repository.
5. Procedures to ensure data security, privacy and confidentiality in the
transfer process and while the data resides at the SCC. The applicant must
include evidence and knowledge of legal issues pertaining to the collection
and analysis of data. When relevant, specific state and/or federal laws and
their impact on the project must be fully explained.
6. Plans and procedures for coordinating and maintaining regular
communications among all the PDCR sites on an ongoing basis.
In addition to its central role in moving the CanCORS Consortium towards
comparable core data collection, the SCC is intended to accomplish several
other research objectives with this initiative, particularly the support and
advancement of statistical methodology for studies of process-outcome linkages
in community cancer care. Statistical analysis of pooled data is the joint
responsibility of investigators from PDCR sites, with collaboration with the
SCC as apppropriate. However, the SCC applicant should demonstrate
familiarity with key statistical concepts relating to the analysis of
observational, population data, such as repeated measures analysis, missing
data, hierarchical modeling, and variability across populations, facilities
and providers. SCC applicants should discuss the development of an
infrastructure for supporting and furthering the development of statistical
methods in collaboration with statisticians at the primary data collection
sites.
In applications, the components of the SCC’s role in facilitating pooled
analysis should include:
1. Plans for data management, including formatting, and documentation of core
data elements using data dictionaries.
2. Methods for reporting the status of data submitted for pooled data
analysis in terms of completeness and utility for pooled analysis.
3. Plans for collaborating with research sites as appropriate to identify or
develop statistical methods, and commitment to providing leadership in
advancing statistical methodology.
The research plan pertaining to the SCC’s role in data coordination and
management for the core study is limited to no more than 25 pages, and should
use the following topic headings:
1. Research objectives and aims
2. Data management, training, and quality control
3. Analysis and statistical methodology
4. Communication
5. Scientific leadership and dissemination
Each applicant to the SCC must submit at least one but not more than three
separate research plan(s) for special research projects entailing data
collection techniques, or advances in statistical methodology or measurement.
There is an additional five page limit allowed to describe the research plans
for each of these special projects. If several projects are proposed, separate
budgets should be submitted for each one.
The research plan for special studies should use the following topic headings:
1. Research objectives and aims
2. Background and significance
3. Research methods and design. Include specific details on how the sample
would be drawn from among participants in the core study.
4. Preliminary analysis plan with statistical methods proposed.
General Instructions for All Applications
Because the Terms and Conditions of Award will be included in all awards
issued as a result of this RFA, it is critical that each applicant include
specific plans for responding to these terms. Plans must describe how the
applicant will comply with NCI staff involvement as well as how all the
responsibilities of awardees will be fulfilled.
Each applicant must describe the proposed duties and attendant necessary
qualifications required for all other proposed personnel, such as project
managers, pathology coordinators, statisticians, data managers, computer
programmers, and data entry clerks. Each applicant must have a defined space
for administrative activities and administrative personnel which will serve as
a focus for data management, quality control, and communication.
Each applicant should budget for investigators to attend semi-annual meetings
over the duration of the 5-year term. In addition, each applicant should
budget for hosting two meetings of the CanCORS Consortium investigators over
the duration of the 5-year term.
A statement of commitment from each participating institution or organization
and/or documentation of collaborative arrangements must be provided.
Multiple research affiliations and related funded research are permitted,
provided they are not conflicting. The affiliation agreements must state
specifically how the problem of competing projects will be resolved.
The RFA label available in the PHS 398 (rev. 4/98) application form must be
affixed to the bottom of the face page of the application. Type the RFA number
on the label. Failure to use this label could result in delayed processing of
the application such that it may not reach the review committee in time for
review. In addition, the RFA title and number must be typed on line 2 of the
face page of the application form and the YES box must be marked.
The sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to
allow for this change. Please note this is in pdf format.
Submit a signed, typewritten original of the application, including the
Checklist, and three signed photocopies, in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Room 1040 - MSC 7710
Bethesda, MD 20892-7710
(20817 for express service)
At the time of submission, two additional copies of the application must also
be sent to:
Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8109, MSC-8329
Rockville, MD 20852 (express courier)
Bethesda, MD 20892-8329
Applications must be received by January 24, 2001. If an application is
received after that date, it will be returned to the applicant without review.
The Center for Scientific Review (CSR) will not accept any application in
response to this announcement that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. The CSR will not accept any application that is essentially the
same as one already reviewed. This does not preclude the submission of a
substantial revision of an application already reviewed, but such an
application must follow the guidance in the PHS Form 398 application
instructions for the preparation of revised applications, including an
introduction addressing the previous critique.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by the National Cancer Institue. Incomplete and/or non-
responsive applications will be returned to the applicant without further
consideration.
Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
the Division of Extramural Activities of the National Cancer Institute in
accordance with the review criteria stated below. As part of the initial
merit review, all applications will receive a written critique and undergo a
process in which only those applications deemed to have the highest scientific
merit, generally the top half of the applications under review, will be
discussed assigned a priority score, and receive a second level review by the
National Cancer Advisory Board.
Review Criteria
The general criteria to be used in the evaluation of grant applications are
listed below, followed by specific criteria for primary data collection sites
and the SCC.
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. The
reviewers will comment on the following aspects of the application in their
written critiques in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. Each of these
criteria will be addressed and considered by the reviewers in assigning the
overall score weighting them as appropriate for each application. Note that
the application does not need to be strong in all categories to be judged
likely to have a major scientific impact and thus deserve a high priority
score. For example, an investigator may propose to carry out important work
that by its nature is not innovative but is essential to move a field forward.
The review group will examine: the appropriateness of proposed project budget
and duration; the adequacy of plans to include both genders and minorities and
their subgroups as appropriate for the scientific goals of the research and
plans for the recruitment and retention of subjects; the provisions for the
protection of human and animal subjects; and the safety of the research
environment.
Specific Review Criteria: PDCR Sites
The following factors will be considered in evaluating the merit of
applications for the PDCR sites:
1. Significance: Scientific, technical, or medical significance and
originality of each research project within the application that includes
specific proposed core research hypotheses relating processes of lung and/or
colorectal cancer care to health outcomes.
2. Approach: Plans and methods for the initial recruitment and retention of
subjects, and appropriateness of plans to develop a high-quality data
collection infrastructure using multiple data sources including pathology
facilities, medical records, patients, and providers. Specifically, reviews
should assess the following:
A. Availability of a heterogeneous population and health delivery systems
for surveillance coverage that complements the proposed research. Adequacy of
plans to include minorities and their subgroups, as appropriate for the
scientific goals of the research. Plans for enrolling a minimum number of
cases (1,000 per cancer type) enrolled over a 2-year accrual period.
B. Proposed rapid case ascertainment system to enroll study subjects
within the first 6 months following initial diagnosis; linkages available to
achieve this through existing cancer registry or other resources.
C. Proposed methods for conducting mix-mode patient surveys and medical
record reviews from inpatient and outpatient sources of care;
D. Proposed methods for retaining subjects over the course of follow-up,
and plans for obtaining information about care delivered throughout all phases
of cancer care.
E. Plans for obtaining cooperation of patients, next-of-kin, and providers
such as oncologists, surgeons, radiologists, pathologists, primary care
physicians, nurses, and tumor registrars, etc., necessary for successful data
collection efforts.
F. Plans for development of systems for data collection, formatting and
transfer of data to the SCC.
G. Procedures for ensuring confidentiality, and quality assurance and
control practices to ensure the records and data of all research subjects will
be protected.
H. Scientific and technical merit of statistical methods for analyses of
proposed core research hypotheses.
I. Scientific and technical merit of proposed special research studies
(non-core).
3. Innovation: Does the project employ novel concepts, approaches or methods
with regard to collection of data on process and outcomes of community cancer
care? Does the project challenge existing paradigms or develop new
methodologies or technologies? Are novel or innovative statistical methods
and approaches proposed for analyzing proposed core research hypotheses and
data collected within special research projects?
4. Investigators: Qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the area of the
proposed research should include:
A. Demonstration of a track record of interdisciplinary activity.
B. Experience in the collection of primary data and management of large
data sets.
C. Personnel with credentials and experience in cancer care health
services research, particularly those related to the clinical study of lung or
colorectal cancer, epidemiology, biostatistics, data management and computer
programming.
D. Adequacy of time (effort) that the Principal Investigator and staff
would devote to establishing the core database and conducting the
proposed studies.
5. Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
The initial review group will also examine: the appropriateness of proposed
project budget and duration; the adequacy of plans to include both genders and
minorities and their subgroups, and children as appropriate for the scientific
goals of the research; the provisions for the protection of human and animal
subjects; and the safety of the research environment.
Specific Review Criteria: SCC
The following factors will be considered in evaluating the scientific merit of
applications for the SCC:
1. Significance: Scientific and technical merit of plans and procedures
relating to managing and coordinating collection of core data, support for
analysis of pooled data by all CanCORS investigators, and providing leadership
in development of statistical methods.
2. Approach: Appropriateness of plans to develop data collection, formatting
and transfer practices to conform to standards to be determined by CanCORS
investigators for pooled data analysis, specifically:
A. Plans for setting up effective data formatting and transfer systems to
ensure conformation to standards set by the Consortium and to facilitate
pooled data analysis. Plans for development and testing of automated
information systems to ensure and facilitate reporting of standardized core
data elements by participating research sites to the SCC.
B. Planned methods for defining and documenting standardized, core data
elements for processes of care from medical records and self-reported data on
patient history, quality of life, satisfaction, and other outcomes relevant to
the primary research questions; plans for design and development of standard
data collection forms to collect core elements determined by the CanCORS
Consortium; and procedures for implementing centralized training of all
survey and medical abstract personnel.
C. Plans and procedures to support the development of uniform quality
control procedures for data collection within PDCR sites, and procedures for
ensuring quality control of transmitted core data submitted by PDCR sites to
the SCC.
D. Plans to protect data transmitted and stored at the SCC as part of
protection of research subject confidentiality.
E. Plans to solicit cooperation and maintain communications among all
participating PDCR sites, including a description of planned site visits to
PDCR sites to facilitate the collection of core data and conduct of pooled
analytic research.
F. Scientific and technical merit of statistical methods to be developed
and/or applied to analysis of core data.
G. Scientific and technical merit of proposed special research studies.
3. Innovation: Scientific significance and originality of:
A. Procedures for coordination and quality control of core research data
reported to the SCC.
B. Statistical methods to measure and analyze the outcomes of cancer
care in the community setting.
4. Investigator: Qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the area of the
proposed research should include:
A. Demonstration of a track record of interdisciplinary activity,
particularly in terms of coordinating large data collection efforts and
conducting pooled data analysis.
B. Experience in the management of large primary data sets and
participation in collaborative studies.
C. Personnel with credentials and experience in supporting the activities
of the SCC, including biostatistics, computer systems programmer/analyst, and
project coordinating and data entry.
D. Adequacy of time (effort) that the Principal Investigator and staff
would devote to establishing the database and conducting the proposed studies.
5. Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
The initial review group will also examine: the appropriateness of proposed
project budget and duration; the adequacy of plans to include both genders and
minorities and their subgroups, and children as appropriate for the scientific
goals of the research and plans for the recruitment and retention of subjects;
the provisions for the protection of human and animal subjects; and the safety
of the research environment.
AWARD CRITERIA
The anticipated date of award is September 2001. In the final funding
selection process of peer-reviewed and scored applications, NCI program staff
will make funding decisions on the basis of the following criteria:
1. Scientific and technical merit as determined by peer review.
2. Appropriateness and duration of the proposed budget in relation to the
proposed research.
3. Appropriate mix of minorities and persons of lower socioeconomic status in
the core study samples overall, and rural/urban and geographic balance among
the primary data collection research sites.
4. Diversity of health care delivery systems with respect to organization
and reimbursement within the Consortium as a whole.
5. Availability of funds.
Applications recommended by the National Cancer Advisory Board will be
considered for award based upon the above criteria.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and
their sub populations must be included in all NIH supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification is provided that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing research involving human subjects should read the
updated "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS.
Because lung and colorectal cancers are diseases of older persons, the
research issues under study in this RFA are not relevant to children.
Therefore, applicants may use Justification 1: the research topic to be
studied is irrelevant to children; from the policy announcement. The
following information is provided to ensure that all NIH applicants are aware
of the policy.
It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are clear and compelling scientific and ethical reasons not
to include them. This policy applies to all initial (Type 1) applications
submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
“NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects” that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Investigators may also obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This RFA, Cancer Care Outcomes Research
and Surveillance Consortium, is related to the priority area of cancer
surveillance and data systems. Potential applicants may obtain a copy of
"Healthy People 2010" at http://www.health.gov/healthypeople/.
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.399, Cancer Control Research. Awards are made under authorization of
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241
and 284) and administered under NIH grants policies and Federal Regulations 42
CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-use of all tobacco products. In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the PHS
mission to protect and advance the physical and mental health of the American
people.
REFERENCES
. Breslow L, Bailar JCI, Brown BW, Brown HG, Darity WA, Defendi V, et al.
Measurement of progress against cancer. JNCI 1990. 82:825-835.
2. Hewitt M and Simone JV, eds: Ensuring Quality Cancer Care. National Cancer
Policy Board, IOM. National Academy Press, Washington, D.C. 1999.
http://books.nap.edu/catalog/6467.html